FDA Adverse Event
Malfunction
Summary report: N
9616026-2006-00244
MDR report key: 728507
·
Received June 22, 2006
Report
- Report Number
- 9616026-2006-00244
- Event Type
- Malfunction
- Date Received
- June 22, 2006
- Product Code
- FII
- PMA / PMN Number
- k041005
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PT INJURY WAS REPORTED. A GAMBRO FIELD REP COULD NOT DUPLICATE THE FAILURE. THE FIELD REP CLEANED AND RESEATED VIDEO AND TOUCH-SCREEN CONTROLLER CONNECTORS. THE MACHINE WAS TESTED TO MFR'S SPECIFICATION. 510(K)# IS K041005
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |